Metrics Plan for Facility, Utility, System and Equipment

As October rolls around I am focusing on 3 things: finalizing a budget; organization design and talent management; and a 2025 metrics plan. One can expect those three things to be the focus of a lot of my blog posts in October.

Go and read my post on Metrics plans. Like many aspects of a quality management system we don’t spend nearly enough time planning for metrics.

Metrics Plan

So over the next month I’m going to develop the strategy for a metrics plan to ensure the optimal performance, safety, and compliance of our biotech manufacturing facility, with a focus on:

1. Facility and utility systems efficiency
2. Equipment reliability and performance
3. Effective commissioning, qualification, and validation processes
4. Robust quality risk management
5. Stringent contamination control measures

Following the recommended structure of a metrics plan, here is the plan:

Rationale and Desired Outcomes

Implementing this metrics plan will enable us to:

• Improve overall facility performance and product quality
• Reduce downtime and maintenance costs
• Ensure regulatory compliance
• Minimize contamination risks
• Optimize resource allocation

Metrics Framework

Our metrics framework will be based on the following key areas:

1. Facility and Utility Systems
2. Equipment Performance
3. Commissioning, Qualification, and Validation (CQV)
4. Quality Risk Management (QRM)
5. Contamination Control

Success Criteria

Success will be measured by:

• Reduction in facility downtime
• Improved equipment reliability
• Faster CQV processes
• Decreased number of quality incidents
• Reduced contamination events

Implementation Plan

Steps, Timelines & Milestones

1. Develop detailed metrics for each key area (Month 1)
2. Implement data collection systems (Month 2)
3. Train personnel on metrics collection and analysis (Month 3)
4. Begin data collection and initial analysis (Month 4)
5. Review and refine metrics (Month 9)
6. Full implementation and ongoing analysis (Month 12 onwards)

This plan gets me ready to evaluate these metrics as part of governance in January of next year.

Management Review – a Structured Analysis of Reality

In October I will breakdown some metrics, explaining them and provide the rationale, and demonstrate how to collect. I’ll be striving to break these metrics into key performance indicators (KPI), key behavior indicators (KBI) and key risk indicators (KRI).